CRO Oversight for a Successful Clinical Trial

Date: May 29-30, 2025
Duration: 2 Days
Time: Starts at 9 AM EST

Many pharmaceutical, biotechnology, and medical device companies engage one or more Clinical Research Organizations (CROs) to conduct their clinical trials. However, managing a study through a CRO presents unique challenges compared to in-house operations, yet companies frequently lack formal training for this transition. Moreover, the recent update to the ICH Good Clinical Practice (GCP) guidelines underscores the Sponsor’s responsibility to actively oversee their trials. Regulatory agencies are increasingly scrutinizing this aspect, identifying it as a potential weakness within Sponsor companies. This workshop addresses these critical issues by providing comprehensive training on effective CRO oversight. Participants will gain the knowledge and skills necessary to navigate the complexities of managing CRO-run projects, ensuring regulatory compliance, and optimizing trial outcomes. Through interactive sessions and practical insights, attendees will learn how to enhance their oversight practices and strengthen their organization’s approach to clinical trial management.
 
Who Will Benefit:
  • Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
  • Medical and Technical writers
  • Project Managers, Directors
  • Supervisors, and lead workers in Regulatory Affairs
  • Quality Assurance and Quality Control
  • IT professionals looking to make eCTD submissions

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Day One :Understanding Clinical Research Organization (CRO) Oversight

9:00 AM – 10:00 AM: Lecture 1: Clinical Research Organizations (CROs) Importance

  • Role of CROs in clinical research​ 
  • Key functions and services
  • Importance of CRO oversight in clinical trials

10:00 – 11:00 AM: Lecture 2: Overview of Working with a CRO

  • Responsibilities of sponsors, CROs, and investigators in ensuring regulatory compliance
  • Common regulatory compliance issues and their impact on clinical trials
  • Types of Contracting Models
  • Current CRO business model
  • Contract versus project management
  • Overview of CRO Management Steps – RFP, Contract, Oversight, Change in Budget and/or Scopes  

11:10AM – 11:15 AM: Break

11:15 AM – 12:30 PM: Lecture 2: CR) Oversight:

  • Schematic workflow of a Sponsor/CRO project
  • GCP requirements
  • Budget requirements
  • Company requirements (the extent to which it must be done your way)
  • Measurements/KPI’s
  • Standardized Metrics, Reports, Meeting, Visits in trial sites

CRO Oversight Continued:

  • Matrix of responsibilities
  • Matrix of valid SOPs
  • Vendor oversight plan
  • Vendor oversight visit template​

1.30 – 2:00 PM: Break

2:00 – 3:00 PM: Regulatory Framework for CRO Oversight

  • Overview of regulatory bodies governing clinical research (FDA, EMA, etc.)
  • Guidelines and regulations pertaining to CRO oversight (ICH GCP, FDA regulations, etc.)
  • Responsibilities of sponsors, CROs, and investigators in ensuring regulatory compliance
  • Common regulatory compliance issues and their impact on clinical trials

3:00 – 3:15 PM: Break

3:15– 4:15 PM: Lecture 3: Risk-Based Approach to CRO Oversight

  • Introduction to risk-based monitoring (RBM) and its application in CRO oversight
  • Identifying and assessing risks associated with CRO activities
  • Developing risk mitigation strategies for CRO oversight
  • Case studies and practical examples illustrating the implementation of RBM in CRO oversight

Day Two :Implementing Effective CRO Oversight Practices

​9:00 AM – 10:00 AM: Lecture 4: Establishing CRO Oversight Plans

  • Components of a comprehensive CRO oversight plan
  • Defining key performance indicators (KPIs) for CRO oversight
  • Developing a risk assessment matrix for CRO activities
  • Creating communication and escalation protocols for effective oversight

​10:00 AM – 11:00 AM: Lecture 5: Sponsor/Vendor Communication

  • CRO Meetings
  • Effective communication plan
  • Mode of communication
  • Feedback and resolution 

Break: 11:00 AM – 11:15 AM:

11:15 AM – 12:00 PM: Lecture 6: CRO Qualification Analysis

  • Criteria during selection phase
  • Evaluation of different selection tools
  • Bid defence meeting
  • Qualification Visit or Audit
  • Standardised Bid-grid/Template
  • Standardised Questionnaire

12:00 PM – 1:30 PM: Break

​Request for Proposal (RFP)

  • How your anticipated relationship and oversight should affect your RFP
  • How your selection criteria should affect your RFP (e.g. use of a bid grid)

On-going Changes in the Project

  • Recognizing changes in scope and budget renegotiation 
  • Budget tracking and income 
  • Dealing with requests for budget increase

Types of Sponsor CRO Relationship

  • Preferred provider model
  • Single provider model
  • Size of CRO (Local/MNC’s

Break: 1:30 PM – 2:00 PM

2.00 PM – 3:00 PM: Lecture 7: Monitoring CRO Performance

  • Tools and methodologies for monitoring CRO performance (metrics, site visits, audits, etc.)
  • Establishing performance metrics and benchmarks for CRO activities
  • Conducting regular performance evaluations and assessments
  • Addressing performance issues and implementing corrective actions

3:00 – 4.00 PM: Lecture 7: Building Collaborative Relationships with CROs

  • Importance of fostering collaboration and communication with CROs
  • Strategies for establishing and maintaining effective partnerships with CROs
  • Best practices for managing relationships between sponsors and CROs
  • Case studies highlighting successful collaborations between sponsors and CROs
  • ​Analyzing and discussing real-life case studies related to CRO oversight

Register Online (By clicking on the links below)

Single

Individual

$ 1199

Corporate

5 People

$ 3999

Corporate

10 People

$ 7999

​​Prices are in US Dollars.

The registration fee includes the workshop and all related course materials.

Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com

Payment:
We accept credit card, debit card, and PayPal.

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.

For more info, fill the box below. We will contact you within 24 hrs.